This Funding Opportunity Announcement (FOA) is developed
as a Common Fund initiative (http://commonfund.nih.gov/) through the NIH Office of the
NIH Director, Office of Strategic Coordination (http://dpcpsi.nih.gov/osc/).
The FOA will be administered by the National Human Genome Research Institute
(NHGRI/NIH), (http://genome.gov) on behalf of
the NIH.

Participating Institutes:

National Human Genome Research Institute (NHGRI)Eunice Kennedy Shriver National Institute of Child
Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Neurological Disorders and Stroke (NINDS)
Office of AIDs Research (OAR)
Fogarty International Center (FIC)
Office of Strategic Coordination (Common
Fund)

October 14, 2011 - See Notice NOT-RM-12-002. The purpose of this Notice is to revise the wording of the following passages; Section IV, 2. Page Limitations, Section IV, 2. Administration and Management, Section IV, 2. Under Collaborations and Section I, Part 2.

October 14, 2011 - See Notice NOT-RM-12-004. The purpose of this Notice is to provide additional information to those applicants who plan to include an advisory committee.

This NIH Funding Opportunity Announcement (FOA), supported
by funds from the NIH Common Fund (Common
Fund) and participating NIH Institute(s) and Center(s), invites applications
from foreign Institutions in African countries who wish to develop the study
of genomic/genetic/environmental contributors of human health and disease
within Africa, using cutting edge research tools to understand health and
diseases affecting African populations more completely and increase capacity for
biomedical research, in terms of building infrastructure (including data and
research resources), genomic proficiency of researchers and numbers of trainees.
In partnership with the Wellcome Trust, the H3Africa initiative is focused on
supporting these efforts as part of an effort to promote sustainable research
in Africa that will promote health and combat disease.

The purpose of this FOA is to call for applications for
research centers called H3Africa Collaborative Centers. Awards will focus on
supporting research on the genetic/environmental contributors to health and
disease in Africa that fall within the mission of the NIH, which is to seek
fundamental knowledge about the nature and behavior of living systems and to
apply that knowledge to enhance health, lengthen life, and reduce the burdens
of illness and disability.

Key Dates

Posted Date

August 23, 2011

Letter of Intent Due Date

September 30, 2011

Application Due Date(s)

December 2, 2011

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review

February/March, 2012

Advisory Council Review

May, 2012

Earliest Start Date(s)

July, 2012

Expiration Date

December 3, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the PHS398
Application Guide except where instructed to do otherwise (in this FOA or
in a Notice from the NIH Guide
for Grants and Contracts). Conformance to all requirements (both in
the Application Guide and the FOA) is required and strictly enforced. While
some links are provided, applicants must read and follow all application
instructions in the Application Guide as well as any program-specific
instructions noted in Section IV. When
the program-specific instructions deviate from those in the Application Guide,
follow the program-specific instructions. Applications that do not
comply with these instructions may be delayed or not accepted for review.

Looking ahead: NIH is committed to transitioning all
grant programs to electronic submission using the SF424 Research and Related
(R&R) format and is currently investigating solutions that will accommodate
NIH’s multi-project programs. NIH will announce plans to transition the
remaining programs in the NIH
Guide to Grants and Contractsand on NIH’s Applying
Electronically website.

Low- and middle-income nations suffer over ninety percent of
the world’s burden of premature mortality, as measured in lost years of life.
These countries, constituting three-quarters of the world’s population, now
must deal with a triple burden: the persistent cluster of infectious
diseases, malnutrition, and a growing incidence of chronic disease and
disabilities due to increased life spans and new risk exposures that accompany
it. The NIH has a long-standing commitment to address both communicable and
non-communicable diseases around the world through health research and
training, and one of NIH’s stated priorities is enhancing efforts in global
health. Genomics and other large-scale biological studies provide
cutting-edge approaches to research on the genetic and environmental
contributors to health and disease, the understanding of which will lead to
unimagined advances in medical science and powerful new ways for improving
human health. To maximize the impact on the health of people globally, advances
in the fields of genetics/genomics/environmental studies must be integrated
into the research conducted in developing countries, as well as into their
medical education and health services. Notably, however, African researchers
and populations are substantially underrepresented in genomics and
environmental research endeavors. For example, it has been found, as
documented in a recent review, that, worldwide, the majority of the thousands
of genetic studies completed to date (about 75%) were conducted exclusively in
populations of European descent and only a fraction of the studies done with
non-European populations came from Africa (Rosenberg NA, Huang L, et al.
(2010). Nat Rev Genet 11(5):356-366). The paradox of limited genomics research
conducted in Africa and the centrality of contemporary African populations for
our understanding of human evolution and population genetics has been widely
noted.

While there are pockets of research excellence in genetics
and environmental studies on the African continent done by African and other
scientists, a limited number of individuals have the expertise to engage in
this work compared to the overall population size and burden of disease there.
It is the objective of the H3Africa Initiative to enhance the capability of
African scientists and research institutions to use genomics and other powerful
new approaches to address problems of African health and disease. Increasing
African research capacity by building infrastructure, expanding the genomic
proficiency of researchers, and increasing the number of well-trained
individuals is essential to promote sustainable efforts to address the
challenges to advancing health and combating disease in Africa. While focused
on benefitting the people of Africa, such research may also be
relevant to the health of individuals in the U.S. and other countries worldwide,
particularly those of African descent. For example, many scientists believe
that different environmental exposures for a population whose genetic
architecture evolved in environments with a scarcity of available resources are
an underlying contributor to disease in the U.S.

H3Africa is a partnership among the National Institutes of
Health (NIH, USA), the Wellcome Trust (WT, UK), and the African Society of
Human Genetics (AfSHG). A set of recommendations for H3Africa was developed by
a pair of working groups, composed primarily of African scientific experts, who
addressed the major scientific, ethical and practical issues in the development
of a large-scale genomics research program in Africa. The working groups
formulated a detailed proposal (which can be found in a white paper at www.h3africa.org) to address the goal of
creating and sustaining a network of African Centers that could carry out training
and research based on state-of-the-art genomics approaches. Through support for
infrastructure development, training, and specific research projects, the working
group recommendations were designed to catalyze genomics and environmental
research concerning human diversity, health, and disease biology of particular
relevance and benefit to African populations and societies. The proposal was
discussed at a public meeting held in Cape Town, South Africa in March 2011 and
the attendees ratified the white paper’s recommendations.

The research program described in this FOA (and a similar
call for proposals from the Wellcome Trust http://www.wellcome.ac.uk/Funding/Biomedical-science/Funding-schemes/Strategic-awards-and-initiatives/wtvm052057.htm ) is a response to the disparities in research capacity noted above and is
based, in significant part, on the recommendations of the H3Africa white paper
and from discussions at the Cape Town meeting. The H3Africa Initiative aims to
contribute to the establishment of a viable, productive, and eventually
sustainable, African research infrastructure to study the genetic and
environmental contributors to disease and health. It aims to do so through a
combination of the leveraging of existing capacity, expertise and
infrastructure with investment in new research, infrastructure-building and
training efforts.

H3Africa has three interrelated, interdependent objectives.
The first is to increase the human resources for conducting cutting-edge genomics-based
research in Africa through training and enhanced collaborations within Africa
and with the African scientific diaspora. The second is to support
cutting-edge research that will not only generate important findings and
discoveries, but will serve as a vehicle for research training and for the
improvement of the research capacity of African laboratories where the research
is carried out. The third is to support the improvement of specific types of
infrastructure, i.e., bioinformatics and biorepository capacity, which are
needed to do genomics-based and environmental research. To achieve these
objectives, the H3Africa program at NIH will comprise the following: Infrastructure
improvement will be addressed by support for an H3Africa Bioinformatics Network
(see companion FOA, RFA-RM-11-010)
and for up to four planning grants for biorepositories in Africa (see companion
FOA, RFA-RM-11-011). It is anticipated that one or more full-scale H3Africa
Biorepositories will be established in Africa after the planning grant/feasibility
phase. A companion FOA to this document (RFA-RM-11-009),
“Human Heredity and Health in Africa (H3Africa): Research Projects” calls for
genomic/genetic research applications from individual investigators who wish to
add a genomics component to an existing disease-based research effort. The
current FOA calls for applications for the H3Africa Collaborative Centers,
which should include opportunities for genomics/genetics /environmental research,
research training, administrative training, and career support in a multi-institution
collaboration . Finally, there will be a small grant program, that will be
funded in FY13, to support research on the societal implications of genomics in
Africa. All awards under the NIH H3Africa program will be made to African
Institutions and the majority of the awarded funds must be spent in Africa. All
awardees will participate in the H3Africa Consortium to further enhance the
collaborative nature of this Initiative.

H3Africa is funded, in part,
through the NIH Common Fund, which supports cross-cutting programs that are
expected to have exceptionally high impact. All Common Fund initiatives invite
investigators to develop bold, innovative, and often risky approaches to
address problems that may seem intractable or to seize new opportunities that
offer the potential for rapid progress.

Research Objectives:

A. Scientific scope

The objective of this FOA is to solicit applications to
establish H3Africa Collaborative Centers (H3ACC) to implement research projects
that will apply genomic approaches to understand the genetic and environmental
contributors to chronic and infectious diseases and health in Africa. Each
H3ACC will be composed of multiple projects that collaborate to provide the
complete capacity needed to carry out a genomics-based research project on a
disease or condition important to Africa. The Centers will have a strong
training and career development component and clear organizational and
management structures.

The scientific focus of applications responsive to this FOA will
broadly be within the scope of human genetic/environmental contributors to
disease and other health-related traits in Africa. The following list provides
examples of the types of topics that may be addressed. It is important to
note, however, that this list is meant only to provide guidance; it is not
exhaustive and appropriate topics are not limited to the examples given here.

The genetic/environmental
contributors to non-communicable disease in Africa. The burden
of chronic diseases in Africa has been difficult to measure because of the
absence of a coordinated process to estimate disease prevalence. However, a
small set of prospective studies and hospital experiences have identified the
increasingly important impact of chronic disease. Examples include a
substantial burden from hypertension, a high mortality rate from stroke, a
rapidly growing threat from diabetes, and an increasing recognition of the
prevalence of mental illnesses. Some clinical and epidemiologic research on
such chronic conditions has been conducted in several sites on the continent,
and clinical expertise can be found in many hospitals and tertiary care
settings related to these conditions. A small number of linkage, candidate
gene, and genome-wide association studies (GWAS) have been completed and have
been able to identify potential new loci involved in disease, as well as
replicate findings from other studies. An appropriate H3Africa project might
involve collection of new or existing samples from one or more populations of interest
from specific site(s). The individuals from whom samples are collected should
be well-phenotyped to ensure that the disease being studied has been properly
diagnosed. Samples may be assayed by, for example, genotyping, exome or whole
genome sequencing, and/or functional genomics methods to fully elucidate the
genetic underpinnings of the disease or trait of interest. Analysis of
exposure data on these individuals could provide evidence about the
environmental factors that, in conjunction with the genetic determinants, could
help explain the etiology of the disease under investigation.

The genetic/environmental
contributors to communicable disease in Africa. Infectious
diseases, including HIV/AIDS, malaria, tuberculosis, leishmaniasis, trypanosomiasis,
schistosomiasis, as well as many others, have historically been a major health
problem in Africa. A variety of genetic and environmental factors contribute
to developing, treating and preventing infectious diseases and their impact. Significant
attention and considerable funding has been given to the study of communicable
diseases, and excellent research facilities for studying them are found
throughout Africa. One of the important aspects of the widespread nature of
infectious diseases and the high rates of infection in populations living in
similar environmental conditions is the considerable inter-individual
phenotypic variability in susceptibility and response to infection, which can range
from asymptomatic to death. Contemporary genomic approaches can help to
understand the role that host genetics plays in these diseases. Similarly, additional
genomic analysis and studies of the genetics of the parasites and vectors
involved in the diseases are needed. HIV/AIDS and malaria are among the most
well-studied communicable diseases in Africa. While NIH will consider study of
the host factors involved in susceptibility to HIV infection and diseases that
are co-morbid with HIV/AIDS (see below) as being responsive, studies of other
infectious diseases are encouraged.

The contribution
of the human microbiome to health and disease in Africa. The
field of metagenomics has been enabled by recent advances in sequencing and
other technologies, and studies of the role(s) of the human microbiome in
health and disease have burgeoned. Changes in the microbiome at particular
body sites have been correlated with the onset or progression of several
diseases, such as Crohn’s disease, psoraisis and bacterial vaginosis. Most
microbiome studies have been done outside of Africa, but given the expectation
that microbiome composition is highly dependent on many environmental factors,
including geographical location, diet, socio-economic status, as well as host
genetics, the relevance of the results of those studies to health and disease
in Africa cannot be assumed. As an individual’s microbiome is expected to make
a significant contribution to health status, studies of the role of the
microbiome in diseases of African interest, and comparative analyses of
microbiomes from healthy cohorts, would be appropriate H3Africa research
projects.

Mendelian
diseases in Africa. Local founder effects and the cultural
practice of consanguineous marriages in many African communities have resulted
in the increased prevalence of monogenic traits across the continent. Recent
studies have demonstrated that exome sequencing of a limited number of
individuals can be used effectively to identify causative mutations in several
Mendelian diseases. An analysis of individuals affected by Mendelian diseases
to identify causative mutations and modifier genes in African populations would
be appropriate H3Africa research projects.

Pharmacogenomics:
Pharmacogenomics research seeks to identify genetic factors that are
responsible for individual differences in drug efficacy and susceptibility to
adverse drug reactions (ADRs). African populations have been underrepresented
in pharmacogenomics research. Yet these populations show the highest levels of
genetic diversity among human populations. Pharmacogenomics can be applied to
numerous treatments of illnesses that plague the African continent, for
example, identification of the genetic variant(s) involved in inter-individual
variability in the response to chemotherapy drugs used in cancer treatment,
drugs used for the treatment of HIV, malaria,and other infectious diseases, as
well as pain medication. Analysis of pharmacogenetic effects in Africans would
be an appropriate H3Africa research project.

While applications submitted in response to this FOA may
propose research in any disease or health area that falls within the broad
areas of genetic/environmental contributors to disease or health research,
there are also specific areas of interest to the NIH components that are
participating in H3Africa. These include:

AIDS and
co-morbidities. Research examining the genetic and genomic
basis of HIV/AIDS disease and its co-morbidities including, but not limited to,
host immune response to HIV infection; interaction of HIV with the host immune
system; genomics in the context of HIV vaccine and microbicide development;
host factors involved in co-infection, including tuberculosis, hepatitis C and
hepatitis B in the context of HIV infection; host factors involved in AIDS-defining
and non-AIDS defining malignancies in HIV-infected individuals; and host
factors involved in complications associated with long-term HIV disease and
antiretroviral therapy (ART), including metabolic disorders, cardiovascular
disease, conditions associated with aging, and neurologic and neurocognitive
disorders.

Neurological disorders and stroke: Research in neurological projects that address the H3 goals are of interest.
Study designs may include a broad range of disciplines, such as molecular
genetics, pharmacogenomics, epidemiology, stigma research, and intervention
research. Quality phenotyping is essential for genetic research;
therefore, collection and analysis of genetic material from individuals
participating in well characterized, neurological-based cohorts materials is of
high interest, particularly in the the areas of stroke and stroke risk factors,
epilepsy, and susceptibility to peripheral neuropathy due to infection or
inflammation, as well as other neurological diseases and disorders.
Applications that enhance the NIH-funded Medical Education Partnership Initiative
(MEPI) training experience are encouraged (http://www.fic.nih.gov/Grants/Search/Pages/Awards-Program-MEPI.aspx).
Applications that use technologies such as mobile technologies that enhance
health, knowledge, or care delivery of neurological disorders are also of
interest.

Genetic
and genomic basis of HIV/AIDS disease, abuse of licit or illicit substances
(including alcohol, tobacco, cannabis, stimulants, opiates), and related
co-infections or co-morbidities: Topics include, but are
not limited to studies of the host and viral determinants of immune responses
to HIV infection in substance users, particularly related to specific disease
phenotypes; the factors related to immune recovery following antiretroviral
treatment in the context of substance use; determinants of susceptibility to
HIV infection among substance users; complications associated with long-term
HIV disease and substance use, such as tuberculosis, HIV/HCV-associated liver
disease, cardiovascular disease, metabolic disorders, and neurologic and
neurocognitive disorders; and viral evolution in association with injection or
non-injection substance use.

B. Implementation of the objectives of H3Africa.

As noted in the Background section, there are several
specific objectives that the H3Africa Program is trying to achieve.
Applications submitted in response to this FOA must address the following:

Interaction
with other programs. The H3Africa requires the collaborative
centers to form partnerships in Africa with institutions that have ongoing
studies and offer infrastructure in the research focus area but are not currently
conducting genomics and environmental research. The objective is to rapidly
expand the cadre of skilled genomicists throughout the continent through
collaborations with expert genomicists, through career building within the
Centers, and via training opportunities offered by the Centers. This is in
addition to the expected training of new students, postdocs, technical support
staff and others within the Collaborative Centers. Collaborations could
leverage existing NIH and WT initiatives in Africa http://www.h3africa.org/resources.cfm,
in addition to other funded activities supported by other U.S. government (USG)
organizations such as the CDC, DOD, HRSA, USAID or non-USG entities such as the
Doris Duke Charitable Foundation and the Bill & Melinda Gates Foundation. The
Common Fund joined forces with PEPFAR to fund one such initiative in 2010,
called the Medical Education Partnership Initiative (http://www.fic.nih.gov/Grants/Search/Pages/Awards-Program-MEPI.aspx),
which is building capacity in medical education, clinical, and research
capacity in Sub-Saharan Africa, and is already establishing infrastructure in
various areas including computational hardware and connectivity, clinical
training including in rural settings, research administration training, and
research ethics training.

Research
plan. The application should describe a well-conceived plan
for the investigation of the genomic, and at the applicant’s discretion the
environmental, contributor(s) to a disease or other health-related condition.
The applicant should provide a compelling justification for the choice of the
condition to be studied and should clearly state how the research proposed will
lead to an improved understanding of its genetic and environmental origin(s).
The application should provide a description of the health impact of the
condition in Africa, and the relationship (if any) to the condition in other
parts of the world. The applicant should present a well-considered plan for accomplishing
the goals of the research applications for both the overall collaborative
center and for each of the collaborating components. The plan for the overall
center should discuss the types of data that will be analyzed and how those
data will be obtained (see below). The plans for the collaborating components
should describe the specific contribution that each component will make to the
identification and acquisition of the samples to be analyzed, the generation of
the data, and the management and analysis of the data.

If the data are to be generated by the
center itself, the applicant’s experience with the necessary technologies, the
costs of generating the data, and the anticipated uses should be addressed.
The availability of samples and supplies should be discussed, as should any
issues of long-term maintenance and servicing of the necessary equipment.

Alternatively, the applicant may choose
to send the samples elsewhere for data generation, for example to other
research centers or to service providers. Such an approach could be taken, for
example, for genotyping, microarray analysis or sequencing. In either case, the
data generator may be in Africa or overseas. In describing this approach, the
applicant should describe how the samples will be prepared for shipment to the
data generator, the type of data expected, and how the data will be returned to
the center for analysis.

The applicant should describe how the
resultant data, whether produced in-house or obtained externally, will be
analyzed, including a discussion of the applicant’s experience with the
relevant analytical technologies and methods.

Sample
collection and Human Subjects Issues. The research plan must
include a detailed plan for sample acquisition (where applicable), storage,
preparation of material needed etc. In particular, investigators are urged to
obtain consent for the wide sharing of samples and data; justification should
be provided if samples and data will not be shared or only shared in a limited
manner. A document entitled "Essential Elements of Informed Consent for
H3Africa Research Projects" may be helpful to applicants in writing their
informed consent documents; this can be found at http://www.h3africa.org/informedConsent.cfm.
A timeline for developing and implementing an informed consent process,
including obtaining IRB approval, must be included in the application.

H3Africa anticipates establishing a
biorepository in Africa starting in 2014. All samples (blood, DNA or cell
lines) are expected to be deposited in the H3Africa Biorepository where they
can be distributed and shared for further research consistent with achieving
the goals of this funding initiative. Sample deposition must occur
expeditiously, no later than the date of the first publication that describes
the samples or by the end of the project, whichever comes first. A statement
of commitment from the applicant institution to send samples to the H3Africa
Biorepository must be included in the application, consistent with achieving
the goals of the H3Africa initiative. This should include a description of the
host country’s policies for sending samples out of the country.

Collaboration. Most of the collaborations in which African biomedical
research scientists have been involved have been with scientists from abroad,
rather than with other Africans. One of the goals of the H3Africa Initiative
is to foster collaborations between and among investigators within Africa in
order to build a larger African scientific community that will lead to more
training opportunities and cutting-edge science on the continent. Such
collaborations will also contribute to sustainability of African genomics
programs. Therefore, applications submitted in response to this FOA will be
required to be structured around significant collaborations with scientists at
other institutions within the applicant’s home country or with scientists in
other African counties. One example of an acceptable collaboration would be
one in which each aspect of the overall research program, such as sample
acquisition, phenotyping, genomic data generation, data analysis, is done by a
separate component. Another example would be one in which a full genomic
analysis is done at each collaborating component on a different sample
population and the results combined for a comparative analysis. These examples
are only intended to be illustrative; the organization of the collaborative
activities will be determined by the investigators involved and the applicants
should propose the set of collaborations that would best achieve the proposed
research objectives. While international collaborations with scientists
outside of Africa may be included, the majority of the collaborative activity
should be within Africa.

All applications must include a
description of the overall set of proposed collaborations, how each
collaborative component will contribute to the functioning of the Collaborative
Center, how the collaborating groups will communicate, and how the overall Collaborative
Center will be managed with collaborations that are not on site. If
appropriate, one of the collaborating components can be a management core.

Training
and Career Building. Establishing the next generation of
African researchers to take advantage of genomic approaches to health research
is a critical objective of the H3Africa program. Therefore, the applications must
include a component which may address either training, or career development,
or both.

Training. In this FOA, “training” is meant to include the
education in science and research techniques of graduate students at both the
MS and PhD levels, of post-doctoral researchers, and of faculty through support
for sabbaticals. It also includes technical training of laboratory staff. Other
types of training will be considered if appropriately justified.Applicants will
have wide latitude in designing the training programs, which may be directed at
as many of those levels as desired and for any period of time. While it is
expected that the majority of training will take place in African institutions,
training opportunities abroad can also be included; in that case a plan for the
return of the trainees back to Africa is required. The training program may
include both coursework, laboratory experience, and mentoring. The applicant’s
training experience should be adequately presented.

Career development. Fostering the careers of recently trained
doctoral-level investigators by recruiting or engaging them in the research
programs as leaders of components is another valuable contribution that the
Collaborative Centers can make to establishing the next generation of African
researchers, and applicants are strongly encouraged to include a career
development component in the application. Start-up funds for new investigators
can be requested to enable them to establish their own laboratories.

A well thought-out plan for the
training and career building program, its applicability to the research and its
long term contributions to the goals of H3Africa should be included. Long-term
sustainability and institutional/governmental commitments to the training
program and the independent career positions established through the Centers
should also be discussed. Applicants should note that the Medical Education
Partnership Initiative (MEPI) is a sister initiative to H3Africa within the
Common Fund's overall Global Health Program. H3Africa applicants are
encouraged to collaborate with MEPI grantees as part of their training program
where possible, in order to take advantage of the training infrastructure and
opportunities available through MEPI.

Bioinformatics. The bioinformatics capacity of the Collaborative Center should be clearly
described, both at the level of the overall center and at the level of each of
the collaborating components. Issues of data acquisition, data management,
data storage, and analytical capability should be addressed. The bioinformatics
tools that will be used for each of those functions, and the applicant’s experience
should be described in the application. These bioinformatics activities may be
embedded within the individual research components or may appear as a separate
bioinformatics core in the Center. Additionally, a bioinformatics research
component, for example new computational tool development, may be included within
the research application as one of the collaborative aspects.

Please note the H3Africa Program will fund
a separate H3Africa Bioinformatics Network (see companion FOA, RFA-RM-11-010)
to provide connectivity among the H3Africa participants, and eventually beyond
H3Africa. The H3Africa Bioinformatics Network will also have the ability to
develop new bioinformatics tools for genomics research in Africa. The Collaborative
Centers and any other H3Africa-funded activity will be required to interact
with H3Africa Bioinformatics Network. Therefore, applicants for a Collaborative
Center award must include a statement from the applicant institution committing
it to collaborating and sharing data with the H3Africa Bioinformatics Network
consistent with achieving the goals of H3Africa.

Infrastructure. To the extent possible, the Collaborative Centers are expected
to utilize existing infrastructure in the research institutions where the
studies will be carried out. A description of existing institutional
infrastructure must be provided in the Resources section of the grant
application. This section should be detailed and well documented. Additional
infrastructure components may be requested in the application.

Equipment. In the first year, up to $250,000 total costs for equipment may be requested
beyond the $920,000 direct cost cap for the Collaborative Center budget (see
Section II, Award Budget, below). The equipment must be used for the research
project and must be well justified. However, these funds will be restricted
for purchase of equipment only, and cannot be used to augment the research
budget. Any request for equipment beyond this $250,000 limit will have to be
included within the $920,000 cap and will, therefore, reduce the amount of
operating research funds. The requests for equipment within the $250,000 limit
for restricted equipment funds should be made separately from additional equipment
requests made from research project funds.

International
Extramural Associates Research Development (IEARD) component.

A Collaborative Center and its host
institution must have an effective administrative infrastructure. It must also
have the ability to provide effective administrative management and careful
oversight of the award and, more generally, of the conduct and support of
research. Funds (up to $35,000 direct costs) must be requested within the
Collaborative Center application to support a program of training in the NIH grant
process. The funds will be used for a training program that will be
administered in conjunction with the National Institute of Child Health and
Development's International Extramural Associates Research Development Award
program (see http://nichd.nih.gov/about/org/dsp).
The training component will support the following for a single
individual from the applicant institution: an initial orientation
implemented through a distance learning component, and a two-week training
curriculum on-site at the NIH (in Bethesda, MD, USA) for a single research
administrator to learn about grants management, NIH policies and procedures,
fiscal accountability and research. Upon return to his or her home
institution, that individual will be responsible for designing and implementing
an Infrastructure Development Plan. The institution will be equally
responsible for approving and carrying out the plan and for providing
sustainable support for it as an ongoing institutional component. The
research administrator will use the funds set aside for this purpose from
the Collaborative Center grant during the period of the grant to improve and
reinforce the institution’s research capacity and research administration
infrastructure (through the Office of Research or Office of Sponsored Projects),
as outlined in the final, approved version of the Infrastructure Development
Plan.

If the institution’s administrative
staff have already received such training or believe they have enough
experience that they do not need this initial training, the application should
provide information about the staff’s level of experience and previous training
received, and should propose an administrative training program that is
appropriate to their level of experience. See Additional Instructions below for
information about what must be included in the IEARD program request.

Societal
Implications Research: Applicants may be interested in including
studies of the societal implications, including ethical and legal issues, of
genomics-based research in Africa into their Collaborative Center application.
Support for such research may be requested as an integral part of one of the collaborative
research projects proposed within the center or as a separate collaborative project
within the Center. As noted above, H3AFrica will also sponsor a small grant
program to fund applications in this area in 2013.

Sustainability: One of the major goals of the H3Africa program is to enable
African scientists to demonstrate their world-class skills through the
establishment of cutting-edge research programs that will lead to more
publications and other evidence of productivity, thereby increasing their
opportunities for future funding through normal competitive grant processes, as
well as through increased investment in research by national governments and
private sources. Applicants should discuss the issue of future
sustainability of their research programs beyond the H3Africa program and how
the Collaborative Center activity will contribute to the on-going stability of
the research efforts of all of the participants in the Center. This section of
the application should refer to the letters of Institutional and National
commitments (see below) to provide an overview of the long term prospects for
sustained research by the Center and each of its components.

Data
Sharing and Release plan: A plan for data and resource sharing
and release is expected for all NIH applications (https://grants.nih.gov/grants/policy/data_sharing/).
Applicants are expected to provide a well thought-out plan for widely sharing
data and resources generated by Collaborative Center to further the H3Africa
goal of encouraging more research by Africans on health and disease in Africa.
An application must have an acceptable Data and Resource Sharing and Release
plan before it can be funded. After the awards are made, the H3Africa
Consortium (see below) will develop a unified plan for data and resource release,
and the application must include a statement that the investigators in the
H3ACC will abide by the Consortium’s data and resource policy. Examples of
current data release guidelines for NIH programs can be found at: http://www.h3africa.org/dataReleasePolicy.cfm

H3Africa
Consortium Meetings: The NIH and the Wellcome Trust plan to
hold two H3Africa Consortium meetings per year, and applicants should request
funds to travel to these meetings in their application. Most of the meetings
will be held in Africa. However, in the first year, one of the Consortium
meetings will be held in London, UK, and in year three, one will be held in
Bethesda, MD. It is expected that each research project and administrative
core (if part of the U54 structure) will bring 1 to 2 people to the meeting.
For the meetings in London and Bethesda, each research project should be
represented by at least the PD/PI and two trainees. Appropriate travel funds
for these meetings must be requested in the application.

Monitoring
and Evaluation Plan: Applications must contain a plan for how
the funds and supported activities will be monitored and evaluated. The plan
should discuss how the project will be assessed and how the applicant will
define, identify, and determine impact. The plan should also discuss how any
necessary modifications indicated as a result of monitoring and evaluation
activities will be effected. To facilitate monitoring and evaluation, applications
should include a well-defined set of yearly milestones for the proposed research
and training activities. The milestones will be negotiated and finalized at
the time of award, and will then be included in the Terms and Conditions of the
award. The milestones will be subject to change only with the NIH Program
Director’s agreement, but will be reconsidered on an annual basis to account
for the Center’s experience and progress. An example of the level of detail
and specificity needed for the milestones can be found in an example set of
acceptable milestones from past genomics projects, posted at http://www.h3africa.org/genomicsProjectMilestones.cfm.

Institutional
and National Commitments: Applications should include letters
from the appropriate institutional official (University or Medical School
President, Dean or Director, or the head research administrator or equivalent) from
all collaborating institutions substantiating the institution’s commitment to
the proposed research. The institution should state its commitment to
overcoming any administrative obstacles to the implementation of the proposal,
such as accommodation for participation by multiple Schools at the university
or collaboration with other institutions within or outside of the applicant’s
country. Appropriate institutional commitment to the program includes the
provision of adequate staff, facilities, and resources that can contribute to
the planned program. As described in preceding sections, the letter should
address institutional commitment to any new faculty whose labs are established
within the Center. It should also address commitment to collaborating and
sharing data with the H3Africa Bioinformatics Network. The letter should also
briefly discuss the institution's plans for sustaining an active program of
scientific research.

As the programmatic activities of this
initiative will support national and international collaborations, letters of
support from the related national ministries such as the Ministry of Science,
Ministry of Health and/or Ministry of Education for each African country with a
programmatic component will be required. The letter should briefly describe the
national policy concerning the development of a national scientific research
program and how the country is addressing the target that the African Union set
in 2006 for each nation to spend 1% of its gross domestic product (GDP) on
research and development (R&D). It is highly recommended that these
letters of support be included with the application. If these are
submitted later, this could impact and delay the review of the application. An
award will not be made without receipt of these letters of support.

In Summary: This FOA calls for applications for H3Africa
Collaborative Centers to carry out the research goals of H3Africa, which
include:

establishment of viable, productive, and eventually sustainable,
African research programs for the study of the genetic and environmental
contributors to disease and health,

improving the research environment by leveraging current expertise
and existing infrastructure with new investments, and

training and career development

exploration of the social implications of genomic research in
Africa (optional in the Collaborative Centers).

The scientific scope of the H3Africa Collaborative Centers
is broad, and may address:

the genetic/environmental contributors to non-communicable
disease in Africa,

the genetic/environmental contributors to communicable disease in
Africa,

the human microbiome in Africans and its contribution to health
and disease,

Mendelian diseases,

Pharmacogenomics,

Other

It is strongly suggested that applications will address the
following:

Research plan, including the qualifications of the PD/PI(s) of
the overall Collaborative Center and of each of the collaborating components.

Sample collection and human subjects issues

Collaboration plans

Training and career development

Bioinformatics, including connection to the H3Africa
Bioinformatics Network

Available infrastructure,

Equipment within the amount of restricted funds available, and in
excess of that amount (if necessary),

Research administrator development

Data sharing and release,

Monitoring and evaluation,

Institutional commitment,

National plans for science

Section
II. Award Information

Funding Instrument

Cooperative Agreement

Application Types Allowed

New

The OER
Glossary and the PHS398 Application Guide provide details on these application
types.

Funds Available and Anticipated Number of Awards

This initiative is supported by NIH Common Fund, Institute(s)
and Center(s) and Offices of the NIH who have signed on to support the
H3Africa initiative. The amount of funding and the number of awards will
rely upon the outcome of peer review, the interests of the NIH institutes,
and the availability of funds.

The total amount of funds available for these awards is
approximately $3.75 million per year for FY12-16, contingent upon receiving
scientifically meritorious applications. Up to 3 awards are anticipated from
this solicitation.

Award Budget

Applications are limited to $920,000 direct costs which
includes salaries, supplies, training, equipment, travel, and other allowed
expenses for research grants. In order to address H3Africa's goals to build
infrastructure each applicant may request up to an additonal $250,000 for equipment.
The request for equipment must be very well justified. In subsequent years
the research plan budget may not exceed $920,000 direct cots. $35,000 direct
costs/year must also be set aside for participation in the International Extramural
Administrative Research Development Program component (see above) under
Implementation of H3Africa Objectives section..

Award Project Period

Scope of the proposed project should determine the project
period. The maximum period is 5 years.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions)

Specifically:

African institutions are eligible for the awards:

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

Common Fund/Roadmap text, Collaborative Research, or
Projects Greater than 5 years Duration: See instructional documents in the NIH
Guide Publishing System for the text to insert.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to
apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations
as described in the PHS398 Application Guide to be eligible to apply for or
receive an award. Applicants must have a valid Dun and Bradstreet Universal
Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.

All registrations must be completed by the application due
date. Applicant organizations are strongly encouraged to start the registration
process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.

The PD/PI should be an established leader in the academic
and scientific area in which the application is targeted and capable of
providing administrative, clinical, and scientific leadership to the
development and implementation of the proposed program.

More than one PD/PI (i.e., multiple PDs/PIs), may be
designated on the application for projects that require a “team science”
approach and therefore clearly do not fit the single-PD/PI model. Additional
information on the implementation plans and policies and procedures to formally
allow more than one PD/PI on individual research projects is available at https://grants.nih.gov/grants/multi_pi.
All PDs/PIs must be registered in the NIH electronic Research Administration
(eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA
that is essentially the same as one currently pending initial peer review
unless the applicant withdraws the pending application. NIH will not accept any
application that is essentially the same as one already reviewed.

Section
IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to
the current PHS 398 application forms in accordance with the PHS 398 Application
Guide.

2. Content and
Form of Application Submission

It is critical that applicants follow the instructions in
the PHS398
Application Guide, except where instructed in this funding opportunity
announcement to do otherwise. Conformance to the requirements in the
Application Guide is required and strictly enforced. Applications that are out
of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

Applications must be prepared using the PHS 398 research
grant application forms and instructions for preparing a research grant
application. Submit a signed, typewritten original of the application,
including the checklist, and three signed photocopies in one package to:

All page limitations described in the PHS398 Application
Guide and the Table of
Page Limits must be followed, with the following exceptions or additional
requirements:

The research Strategy section for each component of the
scientific of the collaborative center is limited to 12 pages in length. If
there is an administrave core, it is limited to 6 pages in length.

Research Plan

All instructions in the PHS398 Application Guide must be
followed, with the following additional instructions:

The application must include a detailed research plan that
is responsive to the objectives of the H3Africa program, as set forth in this
FOA (see Research Objectives). An H3Africa Collaborative Center must comprise
at least three collaborating components that together address one or more of
research areas, examples of which are given in the Research Scope section of
this FOA. At least one of the collaborating components must be outside of the
applicant institution; bi- or multi-national collaborations are encouraged.

An Overall Research Strategy should describe the scientific
objectives of the H3Africa Collaborative Center, the question(s) that will be
studied, the methods and technologies that will be used, the contributions of
each of the collaborating components, and the way in which the collaborations
will synergize. The Collaborative Center’s approach to meeting its
bioinformatics needs, its approach to obtaining informed consent and other aspects
of the protection of research participants (if applicable), and its approach to
issues concerning research animal welfare should all be discussed in this
section. The Overall Research Strategy is limited to 12 pages.

Research strategies for each of the collaborating components
should describe in more detail the specific contribution that the component
will make to the overall success of the Collaborative Center, the methods and
technologies that will be used, the investigator(s)’s experience with
conducting research and employing the appropriate methods and technologies, the
approaches to meeting the bioinformatics needs of the component, the
component’s approach to informed consent and protection of research subjects
(if applicable) and research animal welfare (if appropriate), any other issues
that are specific to the individual component. This section should also
describe the way in which the component will interact with the other components
of the Collaborative Center. The research strategy for each component will be
limited to 12 pages.

Training Program. A description of the Collaborative Center's training
and career development objectives and how it will meet them should be provided
as a separate section, limited to 12 pages in length. The training and career
development activities may be presented separately within the 12-page limit.
The description should address the objectives of the Collaborative Center’s
training and career development activities; how the trainees and new
investigators will be identified; the specific training and career development
activities that will be supported within the Collaborative Center, including
mentoring activities; where the training will take place; opportunities for
cross-training within the Center’s collaborating components (as applicable);
the role of training opportunities outside of the Collaborative Center; and
plans for monitoring the progress of individual trainees and new
investigators.

Administration and Management. The organizational structure of
the Collaborating Center, and the plans for administering, managing, tracking,
and coordinating the activities of the Center and its individual components
should be described in a separate section, limited to 12 pages in length. The
Collaborative Center’s plans for data release, resource release, intellectual
property disposition, and monitoring and evaluation should be included in this
section. If desired, these activities can be included in a separate
Administrative Core.

The Adminstration and Management
section should also include a description of the applicant institution's
current capacity for administration of research grants, including information
about the placement of the designated research administrative infrastructure
(e.g., Office of Research, Office of Sponsored Projects) within the institution
and its line of authority, the institutional provision of resources such as
office space, administrator salary, office equipment and other in-kind
activities, and the applicant institution's plans to support and sustain the
research office. The application should also describe any plans the institution
has for further development of its research administration program.

The H3Africa Collaborative Center award
will include $35,000 in funds per year to support such further development at
the applicant institution. It is expected that by the end of year -01 of the
Collaborative Center award, one or more research administrators will have
received training equivalent to that provided by the NICHD International
Extramural Research Administration Development Award (IEARDA) program. The purpose
of the IEARDA program is to increase the knowledge and/or experience of
research administrators with funding opportunities, grant applications,
research program and project oversight, data management, fiscal accountability,
and scientific reporting requirements of the NIH and other international
research funding agencies, all of which will be important in the adminstration
of the Collaborative Center award. If at least one individual at the
applicant institution who will have significant responsibility for the
management of the Collaborative Center award has participated in the NICHD
program, the application should document that and then describe the applicant institution's
plans to use the specified funds to enhance and further strengthen its research
administration activities. If no individual at the applicant institution has
yet received such training, the specified funds should be used to support an
individual to participate in this program at the earliest possible offering
after an award is made (the NICHD has agreed to accept one person from each
awarded Collaborative Center into its training program). NICHD will review the
qualification of the person nominated before accepting him or her in the IEARDA
program The application should thus identify the person or persons who will be
responsible for administering the Collaborative Center award and a Biosketch
should be provided for each. The application should also include a brief, one
to two page, description of the Center's and applicant institution's plans for
the administration of the award (equivalent to the Institutional Development
Plan of the IEARDA program). Finally, the application should include a
statement of support from the applicant institution that provides approval of
the nominee’s IEARD training periods at home through the distance learning
component and at the NIH for the NIH residency, and provides the release time
for these periods and any financial support needed for training. This statement
of institutional support may be included in the required Letter of
Institutional Support described in the Implementation of the Objectives of
H3Africa section above. More about this program can be found at http://www.H3Africa.org/IAERDinfo.cfm.

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398
Application Guide, with the following modifications:

H3Africa resource and data sharing plans will be agreed to by the
entire network once all the applications are funded. However, applicants must
provide a plan in the application that must be approved by H3Africa program
staff before the application can be funded, consistent with the goals of the
H3Africa initiative.

All applications, regardless of the amount of direct costs
requested for any one year, should address a data sharing plan

Appendix

Do not use the appendix to circumvent page limits. Follow
all instructions for the Appendix (please note all format requirements) as
described in the PHS398 Application Guide.

Foreign Institutions

Foreign (non-US) Institutions must follow policies described
in the NIH
Grants Policy Statement, and procedures for foreign institutions described
throughout the PHS398 Application Guide.

Applications must be received on or before the due dates in Part I. Overview Information. If an application is
received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and responsiveness by components of participating organizations,
NIH. Applications that are incomplete and/or nonresponsive will not be
reviewed.

Applicant Information Meeting, September 21-22, 2011

The H3Africa staff will host a meeting for applicants to
discuss the NIH Funding Opportunity Announcements (FOAs) regarding H3Africa.
The FOAs call for applications for H3Africa research projects, bioinformatics networks,
collaborative research centers and Biorepository planning grants. The meeting
will be held on the 21st and 22nd of September 2011 at the Windsor Golf Hotel
and Country Club in Nairobi, Kenya.

On the 21st of September staff will discuss each FOA, be
available to answer questions and hold proposal writing and grants management
workshops specific to the NIH application process. On the evening of the 21st
and the day of the 22nd of September NIH staff will be available to meet with
applicants individually with the understanding that the general questions they
ask and answers given by staff will be posted on a website.

Applicants interested in meeting separately with staff
should schedule an appointment by sending an email to H3Africa_meeting@mail.nih.gov . A teleconference link will be provided for individuals unable to attend the
first day of the conference. The agenda, information regarding accommodation
and the details of the teleconference can be found here. While
registration for the meeting, except for the teleconference, is not required
please inform H3Africa staff of your intent to attend by sending an email to H3Africa_meeting@nih.mail.gov . This will enable NIH to provide you with any updates or additional logistics
about the meeting.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section
V. Application Review Information

1. Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the Collaborative Center (CC) to exert a sustained, powerful influence on the research field(s) involved,
in consideration of the following review criteria and additional review
criteria (as applicable for the center proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a Collaborative Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the propsed Collaborative Center address an important problem or a critical barrier to progress in the field? If the aims
of the Colllaborative Center are achieved, how will scientific knowledge,
technical capability, and/or clinical practice be improved? How will successful
completion of the aims change the concepts, methods, technologies, treatments,
services, or preventative interventions that drive this field? How will the goals of the proposed Collaborative Center address the goals of H3Africa? How
will collaborations with other institutions both within and outside the country
contribute to the success and sustainability of the program?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers
well suited to the Collaborative Center? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD/PI, do the investigators have
complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed? How does the program promote and support “innovation” that will strengthen and sustain genomics
research in Africa?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the Collaborative Center? Are potential problems, alternative strategies, and benchmarks for
success presented? If the project is in the early stages of development, will
the strategy establish feasibility and will particularly risky aspects be
managed?

If the Collaborative Center involves clinical research, are the plans for 1)
protection of human subjects from research risks, and 2) inclusion of
minorities and members of both sexes/genders, as well as the inclusion of children,
justified in terms of the scientific goals and research strategy proposed? Will the training program proposed be effective in addressing the training goals of
H3Africa? Will the Center support the career building objectives of H3Africa?
Are the bioinformatics data handling and analysis plans adequate to address the
needs of the Center? Is the proposed collaborative nature of the Center
conducive to achieve the Center's goals? Are the evaluation plans, milestones
and timelines proposed appropriate and adequate for the project? Has the issue
of future sustainability been adequately addressed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements? Does the Center take advantage of resources available at the
collaborating institutions? Does the proposal identify and plan to take
advantage of other resources at the participants' institutions, countries or
other countries where necessary?

Additional Review Criteria - Overall

As applicable for the Collaborative Center proposed,
reviewers will evaluate the following additional items while determining
scientific and technical merit, and in providing an overall impact/priority
score, but will not give separate scores for these items.

Center as an Integrated Effort – Overall Impact

Are the efforts at coordination, interrelationships,
cohesiveness, and synergy among the Collaborative Center's components adequate as
they relate to the common theme of the center?

Does the application provide adequate evidence of the advantages
of conducting the proposed research as a collaborative program rather than
through separate research efforts? Will the research efforts taken
together have more impact on the field than each separate project conducted in
isolation? Will the research proposed in individual projects be enhanced
by being part of the Collaborative Center?

Are there adequate mechanisms proposed for regular communication
and coordination among investigators in the Collaborative Center?

Are adequate administrative structures in place for the
day-to-day management of the center, including arrangements for internal
quality control of ongoing research?

Sustainability

Is the Center's plan for sustainability feasible? Will
the Center and/or its components be well-positioned to apply for continued
funding at the end of the project period?

Do the letters of Institutional and National
commitment suggest that the environment is conducive to a sustained research
enterprise?

Do the collaborations among the institutions suggest
viable long-term partnerships?

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed center involves clinical research, the committee will evaluate the proposed plans for inclusion
of minorities and members of both genders, as well as the inclusion of children.
For additional information on review of the Inclusion section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate
animals as part of the scientific assessment according to the following five
points: 1) proposed use of the animals, and species, strains, ages, sex, and
numbers to be used; 2) justifications for the use of animals and for the
appropriateness of the species and numbers proposed; 3) adequacy of veterinary
care; 4) procedures for limiting discomfort, distress, pain and injury to that
which is unavoidable in the conduct of scientifically sound research including
the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable
restraining devices; and 5) methods of euthanasia and reason for selection if
not consistent with the AVMA Guidelines on Euthanasia. For additional
information on review of the Vertebrate Animals section, please refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall

As applicable for the center proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions that exist
in other countries and either are not readily available in the United States or
augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following
Resource Sharing Plans, or the rationale for not sharing the following types of
resources, are reasonable: 1) Data
Sharing Plan: Does the proposed data release plan constitute a good basis
for negotiating a final data release plan? Does the applicant indicate a
willingness to accept the H3Africa's consensus Data Release policy?; 2) Sharing
Model Organisms; and 3) Genome Wide
Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the National Human Genome Research Institute , in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review), will be discussed and assigned an overall
impact/priority score.

Will Receive a second level of review by the appropriate National Advisory Council

Will receive a written critique.

Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all
other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of
review by the appropriate National Advisory Council. The following will be
considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

How well the application addresses the goals of H3Africa

Overall program balance in the H3Africa program

Appeals of initial peer
review will not be accepted for applications submitted to this FOA.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), and other
HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipient’s activities by involvement in and otherwise working jointly
with the award recipient in a partnership role; it is not to assume direction,
prime responsibility, or a dominant role in the activities. Consistent with
this concept, the dominant role and prime responsibility resides with the
awardee(s) for the project as a whole, although specific tasks and activities
may be shared among the awardee(s) and the NIH as defined below.

Definitions

Steering Committee (SC):

The Steering Committee is the primary governing body of the Consortium.
PI(s)/PD(s) of the cooperative agreements, and NIH Program Directors serve on
the committee. See further details about the Steering Committee under
"Joint Responsibilities".

Panel of Scientific Consultants (PSC)

The PSC will be composed of four to six senior scientists
with relevant expertise who are not P.I.s of a cooperative agreement involved
in the H3Africa Consortium. The PSC will be responsible for monitoring and assessing
the progress of the H3Africa Consortium. See more about the PSC below under
this topic .

The PD(s)/PI(s) will have the primary responsibility for:

All aspects of the study, including any modification of study
design, conduct of the study, quality control, data analysis and
interpretation, preparation of publications, and collaboration with other
investigators, unless otherwise provided for in these terms or by action of the
Steering Committee.

Awardees agree to the governance of the H3Africa Consortium rough
the Steering Committee and recommendations from the Panel of Scientific
Consultants.

Awardee(s) will agree to accept close coordination, cooperation,
and participation of NIH H3Africa staff in those aspects of scientific and
technical management of the project as described under "NIH Program Staff
Responsibilities."

Awardee(s) will provide goals and progress toward those goals at
regular intervals as requested by NIH H3Africa staff and will ensure that the
data produced meets the quality standards agreed to at the beginning of the
project by the H3Africa Consortium;

Awardee(s) will ensure that the data are deposited in the
appropriate public database (e.g., GenBank or other, as specified by NIH H3Africa
program staff), that resources developed as part of this project are made
publicly available according to H3Africa Consortium policies, and that results
are published in a timely manner;

Awardee(s) will adhere to the H3Africa policies regarding
intellectual property, data release and other policies that might be
established during the course of this activity consistent with applicable NIH policies,
laws, and regulations;

Awardee(s) will integrate with and connect to the H3Africa
Bioinformatics Network (see FOA RFA-RM-11-010 and deposit samples in the
H3Africa Biorepository that is anticipated to be [t1] established;

Awardee(s) will retain custody of and have primary rights to the
data and software developed under these awards, subject to Government rights of
access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that
is above and beyond the normal stewardship role in awards, as described below:

One H3Africa Project Scientist from each participating Institute will
serve on the Steering Committee and have one vote; the number of NIH votes may
not exceed the number of PI/PD votes on the SC. They and other NIH H3Africa
project team scientists may serve on sub-committees or working groups, e.g.,
data sharing, data release, quality control, core establishment, as appropriate.
The NIH H3Africa Project Scientists may work with awardees on issues coming
before the Steering Committee and other sub-committees and working groups.

The Project Scientists will participate (with the other Steering
Committee members) in the group process of deciding optimal research approaches
and protocol designs, and contributing to the adjustment of research protocols
or approaches as warranted.

The Project Scientists will negotiate goals with the awardees as
necessary; will serve as liaison between the awardees and the Panel of
Scientific Consultants, the appropriate NIH Institute and Center National
Advisory Councils, the H3Africa Working Group made up of staff that
collectively manage the program and the larger international scientific
community; attend all Steering Committee meetings as voting members as
described above; and assist in developing operating guidelines, quality control
procedures, and consistent policies for dealing with recurrent situations that
require coordinated action.

The Project Scientists will periodically report progress to the
Director, Division of Program Coordination, Planning, and Strategic Initiatives
(DPCPSI), of which the Office of Strategic Coordination that manages the NIH
Common Fund is a part of as well as OAR, and to the Directors NHGRI, FIC,
NINDS, NIDA, and NICHD.

The Office of Strategic Coordination (OSC), NHGRI, NIDA, NINDS,
NICHD, and OAR reserve the right to withhold funding or curtail the study (or
an individual award) in the event of (a) substantive changes in, or failure to
make sufficient progress, toward the agreed-upon work scope with which the OSC,
NHGRI, NIDA, NINDS, NICHD, and OAR cannot concur, (b) human subject ethical
issues that may dictate a premature termination.

Support or other involvement of industry or any other third party
in the study -- e.g., participation by the third party; involvement of study
resources or citing the name of the study or NIH support; or special access to
study results, data, findings or resources -- may be advantageous and
appropriate. However, except for licensing of patents or copyrights, support or
involvement of any third party will occur only following notification of and
concurrence by NIH.

Additionally, an agency program official or NIH program director
will be responsible for the normal scientific and programmatic stewardship of
the award and will be named in the award notice. The assigned program
director may also serve as an NIH Project Scientist.

Areas of Joint Responsibility include:

Steering Committee
participation. A Steering Committee (H3ASC)will serve as the main governing
board of the H3Africa Consortium. The Steering Committee membership will
include the NIH Project Scientist(s) and the P.I. of each awarded cooperative
agreement. The Steering Committee Chair will not be an NIH staff member
but will be appointed by NIH H3Africa staff. Additional members may be added by
action of the Steering Committee. Other government staff may attend the
Steering Committee meetings, if their expertise is required for specific
discussions. Because the Consortium will include investigators funded as a
result of this FOA and of other H3Africa FOAs, it is possible that NIH H3Africa
staff will create appropriate subcommittees to handle interests that may be
specific to a set of awardees funded as a result of a specific FOA.

The Steering Committee
will:

Discuss progress in meeting the goals of various H3Africa
projects;

Facilitate coordination and synergy across the entire H3Africa
program;

Develop recommendations for uniform procedures and policies
necessary to meet the goals of the Consortium, for example for data quality
measures and assessment, conventions for data deposition;

Schedule the time for, and prepare concise (3 to 4 pages)
summaries of, the Steering Committee meetings, which will be delivered to
members of the group within 30 days after each meeting. The SC will meet twice
a year with intermittent conference calls.

Each full member (limited to one person
per awarded center, in the case of multiple PIs per center) will have one
vote. Awardee members of the Steering Committee will be required to
accept and implement policies approved by the Steering Committee.

The Panel of Scientific Consultants (PSC):

The PSC will make regular assessments and provide
recommendations to the Directors of NIH funding components about progress of
the H3Africa components toward the goals of the H3Africa program and about continued
support of the components of the H3Africa Consortium.

The PSC will meet at least once a year. During part of this
meeting, there will be a joint meeting with the H3Africa Steering Committee to
allow the PSC members to interact directly with the awardees.

Annually, the PSCs will provide assessments regarding the progress
of the H3Africa Consortium and of the individual components and, as necessary, will
present recommendations regarding any changes that may be necessary in the
H3AFrica program to the Directors of the NIH funding components.

Dispute Resolution:

Any disagreements that may arise in scientific or
programmatic matters (within the scope of the award) between award recipients
and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel
composed of three members will be convened. The three members will be: a
designee of the Steering Committee chosen without NIH staff voting, one NIH
designee, and a third designee with expertise in the relevant area who is
chosen by the other two; in the case of individual disagreement, the first
member may be chosen by the individual awardee. This special dispute resolution
procedure does not alter the awardee's right to appeal an adverse action that
is otherwise appealable in accordance with PHS regulation 42 CFR Part 50,
Subpart D and DHHS regulation 45 CFR Part 16.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH Grants Policy
Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.